Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

38851–38875 of 40449

HighFDA (Devices)·Z-0878-2013·2013-03-06
Medacta Recalls Versafitcup Impacting Rings for Fit Issues
Medacta USA is recalling Versafitcup Impacting Rings because they may not fit properly in the implant shell, potentially causing surgical delays and complications.
Product
Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0885-2013·2013-03-06
Elekta Apex add-on Micro MLC collimator recall for installation defect
Elekta, Inc. is recalling Apex add-on Micro MLC collimators for radiation therapy because incorrect installation may cause the touchguard inhibit to activate and restrict the view restrictions dialog box.
Product
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0893-2013·2013-03-06
Stryker XIA 3 Iliac Screwdriver Recalled Due to Unthreading Risk
Stryker Spine is recalling 46 units of the XIA 3 Iliac Screwdriver because the outer shafts may unthread during surgical use.
Product
Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0895-2013·2013-03-06
Orthofix ISKD Limb Lengthener Recalled for Potential Post-Operative Failure
Orthofix, Inc. is recalling ISKD limb lengtheners because the device may stop distracting after surgery, potentially causing premature bone consolidation and the need for revision surgery.
Product
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0877-2013·2013-03-06
Intel-GE Care Innovations Recalls QuietCare Facility Servers for Software Defect
Intel-GE Care Innovations is recalling 19 QuietCare Facility Servers due to a software defect that may prevent Wander Alerts from being generated.
Product
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0880-2013·2013-03-06
Philips Brilliance CT Scanners Recalled for Software Data Flipping Error
Philips is recalling Brilliance CT scanners because a software anomaly causes Intensity Projection datasets to be flipped and incorrectly labeled left-to-right.
Product
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0889-2013·2013-03-06
Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination
Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 29,690 units distributed worldwide.
Product
Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2013·2013-03-06
Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination
Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 309,400 units distributed worldwide.
Product
VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2013·2013-03-06
Philips GEMINI TF Big Bore PET/CT Systems Recalled for Software Error
Philips is recalling 37 GEMINI TF Big Bore PET/CT systems because a software error may cause generated Intensity Projection data to be flipped and incorrectly labeled.
Product
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed…
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0875-2013·2013-03-06
KY TINGLING JELLY Personal Lubricant Recalled for Lack of FDA Clearance
McNeil-PPC Inc. is recalling KY TINGLING JELLY Personal Lubricant because the product is not cleared for marketing in the US.
Product
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0786-2013·2013-03-06
Philips CT Systems Recalled for Deteriorating Image Quality Phantom Pins
Philips Medical Systems is recalling 1,474 CT scanners because low-contrast pins in the Image Quality phantom deteriorate, preventing required daily checks.
Product
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0873-2013·2013-03-06
KY Sensitive Jelly Personal Lubricant Recalled for Lack of FDA Clearance
McNeil-PPC Inc. is recalling KY Sensitive Jelly Personal Lubricant because the product is not cleared for marketing in the US.
Product
KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0884-2013·2013-03-06
Philips DigitalDiagnost X-Ray System Recalled for Image Rotation Errors
Philips Healthcare Inc. is recalling 551 DigitalDiagnost X-Ray Systems because images may rotate in the wrong direction, causing electronic side markers to be placed incorrectly.
Product
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0882-2013·2013-03-06
Philips GEMINI PET/CT Systems Recalled for Software Data Flipping Error
Philips is recalling 30 GEMINI PET/CT systems because a software error causes Intensity Projection data to be flipped and mislabeled left-to-right.
Product
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations…
Category
Medical Device
Distribution
43 states
ModerateFDA (Devices)·Z-0879-2013·2013-03-06
Baylis Medical Recalls Unsealed Sterile RF Cannulas for Pain Relief
Baylis Medical is recalling 1,780 sterile RF cannulas distributed to Australia because some pouches were not sealed, risking sterility loss.
Product
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0886-2013·2013-03-06
Integra Jarit Monopolar Cable Recall for Updated Safety Warnings
Integra LifeSciences is recalling 22,500 Jarit Monopolar Cables to distribute an addendum to the Instructions for Use. The update emphasizes existing warnings and adds new precautions for electrosurgical equipment.
Product
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0898-2013·2013-03-06
MedComp Recalls 785 PICC Kits Packaged with Incorrect Needles
Medical Components, Inc. is recalling 785 power injectable infusion PICC insertion kits because they were packaged with non-safety needles instead of the safety needles indicated on the label.
Product
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0761-2013·2013-03-06
GE Healthcare Recalls Brivo XR385 X-Ray Systems Due to Software Issue
GE Healthcare is recalling nine Brivo XR385 X-Ray systems in the US due to a software issue affecting visual indications required by regulations.
Product
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0891-2013·2013-03-06
Myco Medical Recalls Technocut Plus Safety Scalpels Due to Sterility Concerns
Myco Medical is recalling Technocut Plus safety scalpels due to labeling errors and defective packaging that may compromise sterility.
Product
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0881-2013·2013-03-06
Philips Medical Systems Recalls Extended Brilliance Workspace X-Ray Scanners
Philips Medical Systems is recalling 39 Extended Brilliance Workspace X-Ray Scanners because a software anomaly may cause generated data sets to be flipped and incorrectly labeled.
Product
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Category
Medical Device
Distribution
43 states
ModerateFDA (Devices)·Z-0703-2013·2013-03-06
GE Healthcare Definium 5000 X-Ray System UI Display Recall
GE Healthcare is recalling Definium 5000 X-Ray Systems because the user interface may display incorrect exposure settings during rapid protocol switching.
Product
GE Healthcare Definium 5000 / 5220493 X-Ray System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0704-2013·2013-03-06
GE Healthcare Definium 5000 X-Ray System UI Display Recall
GE Healthcare is recalling Definium 5000 X-Ray systems because the user interface may display incorrect exposure settings during rapid protocol switching.
Product
GE Healthcare Definium 5000/5220493-2 X-Ray System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0874-2013·2013-03-06
KY SilkE Vaginal Moisturizer Recalled for Lack of FDA Clearance
McNeil-PPC is recalling KY SilkE Vaginal Moisturizer because the product is not cleared for marketing in the US.
Product
KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0890-2013·2013-03-06
Oculus Innovative Sciences Recalls Atrapro Antipruritic Hydrogel Due to Preservative Failure
Oculus Innovative Sciences is recalling Atrapro Antipruritic Hydrogel because stability testing showed insufficient free available chlorine, a preservative required to maintain product safety.
Product
Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0876-2013·2013-03-06
Ultradent Recalls Mislabelled Avex CX Orthodontic Brackets
Ultradent Products, Inc. is recalling 124 units of Avex CX orthodontic brackets due to incorrect labeling. The affected products were distributed nationwide in the US.
Product
Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

38851–38875 of 40449